Position Summary
The Advanced Quality Engineer in our Mentor, OH location has principal responsibility for managing highly complex projects involving the STERIS Quality Management System, service or manufacturing process quality improvements or technical product or service quality improvement. These projects require significant cross-functional participation and support from all levels in STERIS. This role is tasked with leading, (1) acquisition or new site quality system integration, (2) acquisition or new site production and process control integration; (3) quality measurement system implementation; (4) business-wide quality system standardization; and (5) product, service and manufacturing quality technical analysis and improvement.
This role may also have responsibility for leading and executing the quality strategy for multiple manufacturing or service production lines. The Advanced Quality Engineer is also responsible for managing processes and leading projects to maintain and improve the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, EU MDR and other applicable standards.
This position requires working onsite in our Mentor, OH facility Monday through Friday.
Potential travel up to 10 % for training, to visit supplier or other STERIS sites both domestically and internationally (Mexico).
What You'll do as an Advanced Quality Engineer
- Leads the QMS integration of acquisitions or new manufacturing or service sites.
- Leads production and process control integration and improvement for acquisitions and new manufacturing or service sites.
- Leads Quality Management System design, implementation and improvement for new and existing manufacturing and service sites.
- Designs and implements quality measurement systems and improvements for new and existing manufacturing and service sites.
- Analyzes data and trends to ensure acceptance and effectiveness of site quality measurement systems.
- Leads business-wide Quality Management System standardization initiatives.
- Leads key manufacturing and service quality improvement initiatives and strategies.
- Leads and executes the quality strategy for multiple manufacturing or service production lines.
- Develops, implements, maintain and improves complex quality programs such as product and service quality, supplier controls and production/process controls.
- Develops and generate reports and analyses on quality improvement initiatives to present to senior management.
- Provides input to the annual Quality Planning Process.
- Instructs other STERIS employees in quality principles, such as quality systems, problem solving, and valid statistical techniques.
- Directs the work of Quality and other cross-functional staff in the execution of key projects and initiatives.
- Perform all other duties as assigned.
The Experience, Skills and Abilities Needed
Required:
- Bachelor's Degree in Engineering.
- Minimum of 8 years of related experience required. (Manufacturing/Quality Engineering and/or Quality Systems).
- Minimum of 8 years of experience working in an ISO certified environment.
- Experience with medical device or other regulated industries.
- Quality Management System Regulation FDA (QMSR) Certification or familiarity with QMSR/GMP regulations.
- Ability to travel up to 10% for training or to go to supplier or other STERIS sites both domestically and internationally (Mexico).
Preferred:
ASQ Certification, preferred.
Project Management skills and experience.
Experience with design transfer, process harmonization and sustainability.
Knowledge of